Clinical Evaluation Report

Latest Clinical Evaluation Report for Medical Device

A good clinical evaluation report should support strong evidence that the subject medical device achieves its intended purpose without exposing users and patients to risk.

Data collected, assessed, analyzed by the use a specific medical device on human beings by way of clinical trials, literature search, follow-up, market surveillance, preclinical studies, bench testing and other relevant data sourced.

To prove medical device intended purpose achieves without exposing users and patients any risk.

A consolidated document covering full details of the device with the proper conclusion of the studies prepared and submitted by the legal manufacturer to Notified Body is called the clinical evaluation reports.

In another way, CER prepared for the subject medical device as per MDR article 61 & MEDDEV 2.7/1 Rev 4 is considered as a tool to provide the Notified Bodies with a complete overview of the continuous evidence of safety and performance for the medical device.

Due to this reason developing, maintaining and updating medical device CER reports became of higher priority for CE marking across the Globe.

The CER report must be based on data, which may include data from existing literature, human usage experience, human trials, or any combination of the three.

Compared to earlier Rev 3, MEDDEV 2.7/1 Rev 4 has some more requirements that are very difficult to interpret and those new.

It may cause delays in the notified body review process if just updating based on literature strategy without Equivalence device analysis will increase your risk of rejection of report by notified bodies

We offer right strategy starting with GAP analysis of your existing CER report. If required we are here for you to take up the job for updating your present report or develop a new report as per MEDDEV 2.7.1 Rev. 4.

Check below the latest Clinical Evaluation process flow

clinical evaluation report

What is Clinical Evaluation Report Data, Evidence, Investigation and Trials?

Clinical Data means the data generated from the use of a medical device with regard to safety and performance. To prove safety and performance of a medical device, clinical evidence must be provided.

There are two possibilities to generate Clinical Evidence.

  • Clinical data may be collected through clinical investigations
  • Demonstration of safety and performance based on data already published in scientific literature or data for comparable devices through the literature route.

If applicable, both routes of clinical investigation and evaluation via literature must be used in order to prove safety and performance of a medical device before a device may be placed on the market.

The Evidence is intimately tied to the definition of evidence based from practical usage of medical device by doctors, health organizations and the like use actual research that has been tested on patients to determine best practices in medical devices for variety of procedures.

Systematic investigation on one or more human subjects to evaluate the safety and performance of a medical device (either new technology and or device already in use for many years)

CER trials are scientifically controlled studies undertaken in humans to establish or confirm the safety and effectiveness of a medical device by complying with respective legal requirments

What is the criteria for “equivalent” medical device?

Medical Device Regulation 2017/745, Annex XIV, Section 3 makes it clear that the device to which you claim equivalency must have the same technical, biological, and clinical characteristics.

To explain further, the device in comparison might have same technical and clinical characteristics but uses different construction materials cannot be called as equivalent and will not help you with equivalency determination.

Due to above reason, manufactures must have thorough scientific literature search protocol and supporting evidences in place to avoid notified body review comments.

When and how often CER Report should be updated?

In Clause 6.2, its a process that must be carried out throughout the life-time for the medical device.

In all cases, the CER has to be completed during the pre-market phase, to support the demonstration of safety and performance of the medical device before placing it on the market followed by Report, which must be actively updated to demonstrate the continuous safety and performance of the device.

The CER report needs to be updated at least annually for Class 11b & Class III high risk or case of new devices. In other cases every 2 years.

Demonstration of Qualifications and Experience of Evaluators

The person or team creating the report (CER authors and evaluators) must be properly qualified and evidence must be documented.

MEDDEV 2.7/1 Revision 4 requires that each evaluator should fulfill "Statement of Interest" and must also have a higher education degree with 5 years' experience in a similar field of the device in question or 10 years of experience if the degree is not required.

Deviations from these requirements have to be duly justified and documented.

What can go wrong if CER documentation team is not experienced and trained as per Article 61?

  • Obscured understanding of the purpose of the Clinical Evaluation and MDR Article 61.
  • Lack for properly identified procedures.
  • Incorrect route of data retrieval.
  • Wrong identification of literatures of similar/equivalent device and other pertinent data.
  • Wrong identification of equivalent devices.
  • Incorrect appraisal to determine suitability and limitations of data to address the Essential Requirments.
  • Incorrect analysis of the data with respect to safety, performance, acceptability of side-effects.
  • Incorrect analysis of the clinical data with respect to risk benefit profile.
  • Lack of enough CER evidences supporting essential requirements related to safety and performance.
  • Lack of solid justifications to the gaps identified during a clinical evaluation.
  • Lack of alignment of the CER with the risk analysis and risk management.
  • Invalid conclusions on the clinical evaluation.
  • Need of multiple reviews by the notified body.
  • CE Certificate might be with-held by the Notified Body.
  • Loss of money and man-days.

Benefits of using our Documentation and CER Updates Services

We support small, medium and large organization. No matter which type of organizations and customer locations.

  • We are a dedicated and experienced team of 26+ consultants, biomedical engineers and medical writers working from Germany, India & USA.
  • Strong experience in various type of devices Class I, Class Is, Class Im, Class IIa, Class IIb & Class III Medical Device
  • Documents are developed in the cloud so that the clients can view and comment at any point of time anywhere from the world.
  • Economic and Fast (Normally projects are completed within 60-90 days)
  • Projects will be handed-over after Notified Body approval (We never leave you in dark)
  • Friendly Consultants.
  • Payments will be based on progress.
  • Access to various publications, large databases of human usage evidences for various medical devices.
  • High quality and detailed in-house developed procedures, protocols, templets which are modified several times as per comments from multiple Notified Bodies.
  • Strong Post Market Surveillance and PMCF documents which are essential for the successful completion of CER
  • We develop high-quality Risk Management File along with CER Report which is very much essential for the successful completion of Report and CER updates annually.
  • Help manufacturers with Vigilance and product complaint data.
  • In-house and associated Medical practitioners/physicians and surgeons to oversee & guide on critical requirements on end-to-end deliverables

Looking for more information on the medical device CER updates as per MDR article 61 & MEDDEV 2.7/1 Rev 4 throughout device life cycle. Write /Contact us.

Our team will understand more about the device and guide you as required.

Frequently Asked Questions (FAQ)

Any experiment in one or more human subjects to assess the safety or performance of a medical device is called clinical Investigation. (Clinical Trial or Clinical Study are synonymous with Clinical Investigation).

Data from Clinical Investigation will address intended purpose, relevant clinical benefits. This data will be taken into Clinical Evaluation to demonstrate compliance with MDR General Safety and Performance Requirements (GSPR)

Preclinical Evaluation is the evaluation of subject device to collect data in support of the safety and performance of the medical device. Preclinical evaluation must done before clinical trials or usage in Human beings.